The Aptus(Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay(El
FDA 510(k) K983418 · Zeus Scientific, Inc.
510(k) numberK983418
Submission
- Device name
- The Aptus(Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay(El
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- September 29, 1998
- Decision date
- November 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DHR – System, Test, Rheumatoid Factor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5775
- Specialty
- Immunology
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| K160070 | Rheumatoid Factor (RF) Kit for use on SPAPLUSDHR · Traditional | The Binding Site Group , Ltd. | 12/07/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | Immco Diagnostics, Inc. | 09/23/2015SE |
| K102673 | Rheumatoid Factor Immunological Test SystemDHR · Traditional | Phadia US, Inc. | 09/30/2011SE |
| K100499 | Orgentec Rheumatoid Factor EiaDHR · Traditional | Orgentec Diagnostika GmbH | 10/27/2010SE |
| K083080 | Igx Plex Rheumatoid Arthritis (Ra) Assay and Sqidworks Diagnostics PlatformDHR · Traditional | Sqi Diagnostics Systems | 10/29/2009SE |
| K071247 | N Latex RF KitDHR · Traditional | Dade Behring, Inc. | 08/08/2007SE |
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Questions and answers
When was The Aptus(Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay(El cleared by the FDA?
The Aptus(Automated)Application of the Rheumatoid Factor Igm Elisa Test System. an Enzyme Linked Immunosorbent Assay(El (K983418) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 50 days after the submission was received.
What is the product code of K983418?
The FDA product code is DHR – System, Test, Rheumatoid Factor, a Class II (moderate risk) device regulated under 21 CFR 866.5775.